(CE-IVD)

BACKGROUND

The incidence rate of lung diseases is increasing year by year, especially the high incidence of pulmonary infectious diseases and lung tumors, which seriously threaten human health and life safety. At present, lung biopsy and lung tissue samples are often performed only by pathological examination. Although pathological examination can identify most of the benign and malignant lesions, it is seldom applied to the diagnosis of infectious diseases. Clinical microbiological examination plays an indispensable role in infectious diseases diagnosis, medication guidance, hospital infection control, antimicrobial management etc. However, this field still faces major problems such as long sample circulation time. For example, in terms of microbial identification, although there are automatic calibrators, which relatively shortens the time, they are mostly based on the principle of microbial biochemical reaction, and still cannot achieve rapid identification. Therefore, clinical microbiology laboratory urgently needs new testing technology to replace the existing technology and achieve new breakthroughs.

DETECTION STRAIN

DETECTION METHOD 

Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) technology is used to extract nucleic acids from patients' lung tissues. DNA detection technology combined with PCR in vitro amplification and massarray mass spectrometry are used to qualitatively detect the extracted nucleic acids to identify some pathogenic mycobacteria and their subtypes and confirm whether the patient is infected with the microorganism to be tested.

IDENTIFICATION METHOD OF MYCOBACTERIUM SPECIES 

PRODUCT INFORMATION

DETECTION SIGNIFICANCE

Accurately identify common clinical 26 species of Mycobacterium and Mycobacteriumtuberculosis complex group, and can distinguish between tuberculosis and non-tuberculous mycobacteria, clarify the etiology, and realize personalized treatment.

FEATURES & ADVANTAGES

1. Advanced technology: Combined with PCR technology to analyze the nucleic acid molecular level of pulmonary infection bacteria, there is no need for in vitro culture and other processes, reducing manual operation, simple and fast.Only one day for detection results. 

2. Large amount of data: 96 samples can be processed at the same time, and each sample can identify 25 different types or subtypes of pulmonary infectious bacteria at one time.

3. Excellent Specificity: Capable of handling 100 ng of wild-type human genomic DNA without exhibiting non-specific effects.

4. High Sensitivity: It can detect mycobacterial nucleic acid DNA with a content as low as 200 copies in 20 ng of human genomic DNA.

DETECTION PROCESS 

1.Nucleic Acid Extraction

2.Sample Adding

3.Mass Spectrometry Detection

4.Data Analysis

5.Report